Kips Bay Medical is a medical device company focused on manufacturing and commercializing its external saphenous vein support technology, known as eSVS. This device is used in coronary artery bypass grafting surgery and is designed to improve the long-term performance of the saphenous vein graft.

The company announced today that the U.S. Food and Drug Administration (FDA) has granted approval with conditions of Kips Bay Medical’s Investigation Device Exemption (IDE) to include four U.S. study sites in the “eMESH I” clinical feasibility trial of its eSVS Mesh. There is already a study underway in Bern, Switzerland.

This eMESH I domestic clinical feasibility trial is a multi-center, randomized study of external saphenous vein support using the company’s eSVS Mesh in coronary artery bypass surgery. The goal of the study is to demonstrate the initial safety and performance of the eSVS Mesh for use as an external saphenous vein graft support device during such surgeries sufficient enough for the FDA to approve an IDE for a pivotal study in the U.S. Kips expects to enroll up to 120 patients at eight European and four domestic sites.

The initial enrollment in the U.S. will start with five patients. The company will provide the six-month follow-up angiogram data on these patients as well as additional data the FDA requests. The FDA will review this data before approving the remaining 35 U.S. patients for this study as Kips requested. Of course, there is no guarantee that the FDA will issue such an approval.

For further information about Kips Bay Medical and its eSYS Mesh, please visit www.KipsBayMedical.com

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